- Cedent (Boston, MA)
- CRO Regulatory Specialist Job Description The Regulatory Specialist ensures clinical trials operate within a compliant framework while supporting sponsors and ... and GCP requirements. This role serves as the liaison between clinical operations, quality assurance, and regulatory authorities. Reports to: Evidence Generation… more
- Eisai, Inc (Nutley, NJ)
- …with tracking SAE safety reports, collating information and providing updates to the CRO Initiates, tracks and collates clinical trial documentation related to ... knowledge of healthcare providers and KOL contributionsDevelop fundamental understanding for clinical trial execution, CRO responsibilities and the contributions… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. ... guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to...KOLs, Ad Boards for protocol development; Provides input on CRO / ARO Statement of Work and Budget; Establishes… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- OverviewAs an integral part of the Lovelace Leadership Team, the Pre- Clinical Business Development Officer will lead the Institute's strategic growth initiatives by ... business development strategy with a focus on expanding our pre- clinical contract research portfolio and building long-term, high-impact relationships.The Pre-… more
- Eisai, Inc (Nutley, NJ)
- …your profile, we want to hear from you. The Vice President/Head of Global Clinical Operations is a senior leadership role responsible for overseeing all aspects of ... clinical trial execution within a pharmaceutical or biotechnology company....managing and directing related functions such as data management, CRO vendor management, procurement, and contracting.Excellent communication and interpersonal… more
- Janux Therapeutics (San Diego, CA)
- Janux Therapeutics seeks a Director of Clinical Operations to lead early-phase autoimmune clinical trials from its newly announced A daptive Immune R esponse M ... and will be responsible for all aspects of assigned clinical trials. This role also assures adherence to GCP,...deliverables are completed on-time and within budget Vendor (eg, CRO , Biometrics, IXRS, PK/Central Lab, eTMF, Safety) oversight for… more
- Recursion (Salt Lake City, UT)
- …high-dimensional and diverse data sets, and sophisticated analytics. We are seeking a Lead, Clinical Data Manager who can lead and oversee end to end Clinical ... Data Management. You'll also be proactive and be keen to collaborate on clinical development initiatives with cross functional groups within the larger Data Science… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …case review, documentation reviews in collaboration with the ICSR management and CRO /Vendor oversight groups for case processing activities and reports to the ... matter expert in ICSR standards, decision making and trouble shooting. Identifies CRO /vendor training as needed. Reviews overall processes and identifies areas of… more
- The University of Pennsylvania (Philadelphia, PA)
- …health and wellness programs and resources, and much more. Posted Job Title Clinical Research Coordinator B/C Job Profile Title Clinical Research Coordinator B ... University of Pennsylvania is actively seeking a dedicated, full-time Clinical Research Coordinator to join our team. This pivotal...and maintain all documentation required by the sponsor or CRO per GCP - includes source documentation, case report… more
- Boston Scientific (Marlborough, MA)
- …local or global clinical studies. May lead studies executed by a CRO . Provides clinical input for new product development, post market surveillance, ... - whatever your ambitions. About the role: The Senior Clinical Trial Manager (CTM) will be responsible for the...experience working with external vendors and Contract Research Organizations ( CRO ) Preference for a professional with a wide range… more
- Bristol-Myers Squibb Company (Princeton, NJ)
- …of the Global Research organization in BMS and leads late stage clinical , pharmacological and translational research and development activities for the pipeline and ... immunology, cardiovascular and neuroscience. This group integrates laboratory science, clinical trial/biomarkers and asset development as well as disease research… more
- Arrowhead Pharmaceuticals (San Diego, CA)
- Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the ... the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline… more
- Formation Bio (New York, NY)
- …than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of ... processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs from pharma… more
- Alexander Mann Solutions (AMS) (Baltimore, MD)
- …6 month contract with the opportunity for an extension. This role requires CRO leadership recruiting experience. Most positions will be Director and Senior Director ... contractors) Skills & Experience 5+ years of experience recruiting within a CRO (Contract Research Organization) Experience working with leadership level roles is a… more
- Velocity Clinical Research, Inc. (Annapolis, MD)
- …including critical data points when planning for each assigned protocol Develop Quality Control strategies for team member projects Perform clinical duties (eg ... Overview Velocity Clinical Research is an owned and integrated research...members when collecting and correcting data, transferring data to sponsor/ CRO data capture systems and resolving queries Ensure confidentiality… more
- Children's National Hospital (Washington, DC)
- The Clinical Research Program Lead (CRPL) is a senior clinical research professional responsible for the operational logistics and coordination of research ... and that the trial is conducted in accordance with Good Clinical Practice Guidelines, federal and sponsor regulations and guidelines, organizational Policy… more
- Syneos Health Careers (Morrisville, NC)
- …Medicine, Pharmacy, Nursing or equivalent combination of education and experience. * Clinical research organization ( CRO ) and relevant therapeutic experience ... Description Clinical Project Manager II - post-trial access /...organization built to accelerate customer success. We translate unique clinical , medical affairs and commercial insights into outcomes to… more
- Dawar Consulting, Inc. (Tucson, AZ)
- …education and relevant work experience. 2 years' experience of project and/or clinical trial coordinator/management experience in a regulated, CRO , diagnostic, ... leader in life sciences and diagnostics, is looking for Clinical Services Project Manager I (100% Remote) based out...Duration: Long term contract (Possibility of further extension) As Clinical Services Project Manager I, you will manage … more
- The University of Pennsylvania (Philadelphia, PA)
- …and wellness programs and resources, and much more. Posted Job Title Clinical Research Coordinator B (Department of Gastroenterology) Job Profile Title Clinical ... Summary The Division of Gastroenterology Research Team seeks a full-time Clinical Research Coordinator to organize, coordinate and implement different phases of… more
- REGENXBIO (Rockville, MD)
- … CRO and /or healthcare setting required Knowledgeable of clinical research operations, including interpretation and implementation of FDA regulations, GCP/ICH ... you will support and coordinate the logistical aspects of clinical trial management, site management, data review and cleaning...data review and cleaning according to FDA regulations, Good Clinical Practice (GCP) and relevant SOPs and acts as… more
